Cardima Announces FDA Clearance for Tracer Over-the-wire Electrophysiology Microcatheter; Third Major Group of Cardima Microcatheters to be Approved in the United States.

FREMONT, Calif.--(BW HealthWire)--May 20, 1999--

Cardima(R), Inc. (Nasdaq:CRDM) today announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance to market Cardima's Tracer(TM) over-the-wire microcatheter for diagnostic mapping and pacing in the coronary sinus. The Tracer is the only over-the-wire microcatheter available that is designed to allow access to the coronary venous system for epicardial mapping of tachycardias, or rapid heartbeats.

The Tracer microcatheter, along with the Cardima Pathfinder(TM) and Revelation(TM) microcatheters, is the latest addition to Cardima's suite of diagnostic microcatheters that include various numbers of electrodes and configurations. The device, which has a hollow lumen, is like an infusion catheter with electrodes, that can be directed over a conventional guidewire to selected sites within the venous structure of the heart. The Tracer is also approved for sale in Europe and Japan.

"The introduction of the Tracer microcatheter strengthens Cardima's product portfolio in the United States electrophysiology market," said Phillip Radlick, Ph.D., President and Chief Executive Officer of Cardima. "The Tracer, due to its over-the-wire design, will make access easier for physicians who are used to placing guidewire catheters in the heart and the hollow lumen design has the ability to infuse through the device while mapping or pacing, which opens a new dimension in electrophysiology."

Cardima, Inc. designs, develops, manufactures and markets minimally invasive, single-use microcatheter-based systems for the dual purpose of finding and treating the two most common forms of cardiac arrhythmias: atrial fibrillation, a condition of the heart characterized by the irregular and very rapid beating of the heart's atrial chambers, and ventricular tachycardia, a life-threatening condition in which heartbeats are improperly initiated from within the ventricular walls, bypassing the heart's normal conduction system. Cardima is the only company developing unique microcatheter systems to be used in both diagnosing and treating AF and VT. For further information about atrial fibrillation and ventricular tachycardia, contact Cardima's website at www.cardima.com.

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include the Company's ability to conduct successful clinical trials, obtain regulatory approvals and gain acceptance from the marketplace for its products. Additional risks are set forth in the Company's Annual Report on Form 10-K for December 31, 1998 filed with the Securities and Exchange Commission on March 19, 1999 and as amended on March 23, 1999.